PB0562
Gender-related Differences in Venous Thromboembolism Patients: GARFIELD-VTE
P. Prandoni1, A.G.G. Turpie2, A.E. Farjat3, J.I. Weitz4, S. Haas5, W. Ageno6, S.Z. Goldhaber7, S. Goto8, P. Angchaisuksiri9, J. Dalsgaard Nielsen10, G. Kayani3, S. Schellong11, H. Bounameaux12, L. Mantovani13, A.K. Kakkar3, on behalf of the GARFIELD-VTE investigators
1Arianna Foundation on Anticoagulation Bologna, Selvazzano Dentro, Italy, 2Master University, Hamilton, Canada, 3Thrombosis Research Institute, London, United Kingdom, 4McMaster University and Thrombosis and Atherosclerosis Research Institute, Hamilton, Canada, 5Formerly Technical University of Munich, Munich, Germany, 6University of Insubria, Department of Medicine and Surgery, Varese, Italy, 7Harvard Medical School, Boston, United States, 8Tokai University School of Medicine, Department of Medicine (Cardiology), Tokai, Japan, 9Ramathibodi Hospital, Mahidol University, Department of Medicine, Salaya, Thailand, 10Copenhagen University Hospital, Copenhagen, Denmark, 11Municipal Hospital Dresden, Medical Department 2, Dresden, Germany, 12University Hospital of Geneva and Faculty of Medicine, Geneva, Switzerland, 13University degli Studi di Milano Bicocca, Milan, Italy
Main Topic: Venous Thromboembolism
Category: VTE Risk Factors
Background: Venous thromboembolism (VTE) is a common cause of morbidity and mortality worldwide. There is a paucity of research investigating the influence of gender on characteristics, treatment patterns and outcomes in VTE patients.
Aims: Compare the baseline characteristics, treatment patterns, and 12-month clinical outcomes between males and females treated with anticoagulation therapy in the Global Anticoagulant Registry in the FIELD (GARFIELD)-VTE.
Methods: GARFIELD-VTE (ClinicalTrials.gov: NCT02155491) is a global, prospective, non-interventional study of real-world treatment practices. 10,685 patients with objectively confirmed VTE were enrolled between May 2014 and January 2017, 9,709 of which (male n=4897, female n=4812) received anticoagulation therapy and were eligible for analysis in this study.
Results: The distribution of VTE events was comparable (Male: 61.5% deep vein thrombosis (DVT) alone, 38.5% pulmonary embolism (PE) ± DVT; Female: 61.9% DVT alone, 38.1% PE ± DVT). Males and females were similar in both age; mean (standard deviation) 57.6 (15.7) years vs. 57.4 (18.0) years and BMI; mean (standard deviation) 27.9 (5.5) kg/m2 vs. 28.9 (7.5) kg/m2, respectively. Males were more likely to be a current/previous smoker (55.0% vs. 22.6%), but less likely to have been chronically immobilized (4.6% vs. 6.4%) or experienced a recent bleed/anaemia (2.1% vs. 4.5%). No clinically meaningful differences were found between anticoagulation treatment patterns at baseline between genders (Table 1). Over 12-months follow-up, event rates (95% confidence intervals) of all-cause mortality and recurrent VTE in males (vs females) were similar: 6.91 (6.18-7.72) vs 7.55 (6.77-8.40) and 5.02 (4.40-5.73) vs. 4.68 (4.08-5.38) per 100 person-years, respectively. Major and overall bleeding were significantly more frequent in females compared to males (1.32 (1.02 - 1.71) vs 1.91 (1.54 - 2.37) and 12.71 (11.66-13.85) vs. 8.67 (7.83-9.60), respectively (Table 2)).
Conclusions: Despite no differences in anticoagulation treatment at baseline, female VTE patients have an increased risk of bleeding compared to males over 12-months follow up.
Treatment | Male (N=4987) | Female (N=4812) |
| N (%) | N (%) |
Parenteral therapy only | 778 (15.9) | 901 (18.7) |
Parenteral therapy + VKA | 1355 (27.7) | 1268 (26.4) |
VKA only | 273 (5.6) | 276 (5.7) |
DOAC only | 1578 (32.2) | 1526 (31.7) |
Parenteral therapy + DOAC | 875 (17.9) | 788 (16.4) |
Other AC | 38 (0.8) | 53 (1.1) |
[Table 1: Anticoagulation treatment at baseline (± 30 days of VTE diagnosis) in male vs female patients enrolled in GARFIELD-VTE.] Event | Male (n=4897) | Female (n=4812) | P value |
| n | Rate per 100 person-years (95% CI) | n | Rate per 100 person-years (95% CI) | |
All-cause mortality | 310 | 6.91 (6.18-7.72) | 331 | 7.55 (6.77-8.40) | 0.2661 |
Major bleed | 59 | 1.32 (1.02-1.71) | 83 | 1.91 (1.54-2.37) | 0.0292 |
Recurrent VTE | 219 | 5.02 (4.40-5.73) | 200 | 4.68 (4.08-5.38) | 0.4768 |
Any bleeding | 370 | 8.67 (7.83-9.60) | 516 | 12.71 (11.66-13.85) | <0.0001 |
Stroke/Transient Ischemic Attack | 35 | 0.78 (0.56-1.09) | 30 | 0.69 (0.48-0.98) | 0.5933 |
Myocardial Infarction/Acute Coronary Syndrome | 35 | 0.78 (0.56-1.09) | 26 | 0.59 (0.40-0.87) | 0.2846 |
[Table 2: 12-month outcomes in male and female patients enrolled in GARFIELD-VTE.]